Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma
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Purpose
Nimotuzumab (hR3) is an humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the overall survival(OS) and progress-free survival(PFS) of the combination of Nimotuzumab administered concomitantly with TPF in patients with head and neck squamous cell carcinoma.
| Condition | Intervention | Phase |
|---|---|---|
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Head and Neck Squamous Cell Carcinoma |
Drug: Chemotherapy Drug: Nimotuzumab and Chemotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Phase II Study of Nimotuzumab in Combination With TPF for Head and Neck Squamous Cell Carcinoma |
- Disease progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 230 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Chemotherapy
Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Cisplatin(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Fluorouracil(750mg/m²/d,5times/21d, 15times) |
Drug: Chemotherapy
Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Cisplatin(75mg/m²,1 time/21d, 3 times，on day1,22,43); Fluorouracil 750mg/m²/d,5 times/21d, 15times)
Other Names:
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Experimental: Nimotuzumab and Chemotherapy
Nimotuzumab treatment:(200mg/w,6weeks ); Chemotherapy treatment:(Docetaxel(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Cisplatin(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Fluorouracil(750mg/m²/d,5times/21d, 15times),Nimotuzumab treatment:(200mg/w,6weeks ). |
Drug: Nimotuzumab and Chemotherapy
Nimotuzumab treatment:(200mg/w,6weeks ); Chemotherapy treatment:(Docetaxel(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Cisplatin(75mg/m²,1 time/21d,3 times，on days 1,22,43);Fluorouracil (750mg/m²/d,5times/21d, 15times),Nimotuzumab treatment:(200mg/w,6weeks ); Other Names:
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Detailed Description:
Eligible patients had advanced squamous cell carcinoma of the head and neck. Treatment consisted of 3 cycles of docetaxel 75 mg per square meter, followed by intravenous cisplatin 75 mg per square meter) and fluorouracil 750 mg per square meter per day, administered as a continuous 24-h infusion for 4 days) with three cycles. Patients with stable disease who received chemotherapy plus nimotuzumab continued to receive cetuximab until disease progression or unacceptable toxic effects, whichever occurred first.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Joined the study voluntary and signed informed consent form
- Age 18-75，both genders.
- oropharynx,pharynx,oral cavity carcinoma confirmed by pathology.
- Nasopharyngeal cancer 2008 Stages: III/IV.
- At least one lesions can be measured,Conventional measurements ≥2cm, computed tomography(CT) examination ≥1cm .
- Eastern Cooperative Oncology Group(ECOG) Performance Scale 0-2.
- Life expectancy of more than 3 months.
- Use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
- Haemoglobin≥90g/L ,White blood cell(WBC) ≥3×10^9/L
- Hepatic function:ALAT、ASAT< 2.5 x ULN, TBIL< 1.5 x ULN
- Renal function: Creatinine < 1.5 x ULN
Exclusion Criteria:
- Received other anti EGFR monoclonal antibody treatment
- Participation in other interventional clinical trials within 1 month
- Previous received other drug or operative treatment
- Pregnant or breast-feeding women
- History of serious allergic or allergy
- Patients with the history of Serious lung or hear disease
- Other malignant tumor
- not primary tumor(except for primary tumor therapy>3months)
Contacts and Locations| Contact: Wei Guo, MD, PhD, DDS | +86-139 0168 5814 | guoweicn@yahoo.com |
| China, Guangdong | |
| First Affiliated Hospital of Sun Yat-sen University | Recruiting |
| Guangzhou, Guangdong, China, 510000 | |
| Contact: Wei Ran, , MD,PhD ranweigd@gmail.com | |
| China, Jiangsu | |
| Institute of Stomatology of Nanjing Medical University | Recruiting |
| Nanjing, Jiangsu, China, 210000 | |
| Contact: Heming Wu, MD,PhD whmz2002@yahoo.com.cn | |
| Wuxi People's Hospital; Nanjing Medical University | Recruiting |
| Wuxi, Jiangsu, China, 214000 | |
| Contact: Xin Wang, MD,PhD 15301516671 wangxin1975@gmail.com | |
| Xuzhou Central Hospital of Xuzhou city,Dongnan University | Recruiting |
| Xuzhou, Jiangsu, China, 221009 | |
| Contact: Jian Meng, MD,PhD mrocket@126.com | |
| China, Shanghai | |
| 9th People's Hospital, School of Stomatology,Shanghai Jiaotong University | Recruiting |
| Shanghai, Shanghai, China, 200011 | |
| Principal Investigator: Wei Guo, MD, PhD, DDS | |
| Study Chair: | Wei Guo, MD, PhD, DDS | Dept. of Oral and Maxillofacial Surgery,9th People's Hospital, School of Stomatology,Shanghai Jiaotong University |
More Information
No publications provided
| Responsible Party: | Wei Guo, Guo Wei, Shanghai 9th People's Hospital., Shanghai 9th People's Hospital |
| ClinicalTrials.gov Identifier: | NCT01425736 History of Changes |
| Other Study ID Numbers: | BT-IST-SCCHN-008 |
| Study First Received: | August 19, 2011 |
| Last Updated: | August 29, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Shanghai 9th People's Hospital:
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Nimotuzumab Chemotherapy Head and Neck Squamous Cell Carcinoma |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site Docetaxel Cisplatin Fluorouracil |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013